ICH Q7 GMP for APIs | Quality System Templates

ICH Q7, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, is the harmonised guideline developed under the International Council for Harmonisation to fix GMP expectations for API manufacture. Its object is that an API holds the quality and purity characteristics it is represented to possess, which is what protects the finished medicinal product built on it. It reaches across chemical synthesis, extraction, cell culture, fermentation and recovery from natural sources, taking in intermediates as well as final APIs, with controls tightening as processing moves closer to the API itself.

The guideline turns on an independent quality unit and the decisions it owns: batch record review and product release, deviation and out-of-specification investigation, change control, and the handling of complaints, returns and recalls. Around that sit personnel qualification and hygiene; buildings, facilities and equipment; documentation and records; materials management; process and in-process controls; packaging and labelling; storage and distribution; laboratory controls and stability testing; and validation of processes, cleaning and analytical methods, with oversight of contract manufacturers, agents, brokers and repackagers. ICH Q7 is adopted into regional regulatory frameworks, recognised by the FDA and EMA, and underpins EU GMP Part II. Being a guideline rather than a certifiable standard, adherence is tested by regulatory inspection and customer audit rather than by a certificate.